UK expands drug side-effects reporting system

UK patients will now be able to alert regulators to the side effects they experience as a result of taking prescription medicines under a series of amendments to the country’s drug side effect reporting scheme, which come as part of a renewed bid to improve drug safety.

The so-called “yellow card” drug-safety monitoring scheme was first introduced back in 1964, with suspected side effects traditionally reported by healthcare professionals, such as doctors, dentists, and pharmacists, as well as pharmaceutical companies. The system is now being expended to include the general public, which will be able to report side effects either online or via forms that will be made available in doctors’ surgeries, as part of the recommendation from a 2004 review of the scheme. Over 40,000 adverse drug reactions have been submitted to the UK regulator, the Medicines and Healthcare products Regulatory Agency, in the past 40 years, the agency said on its website.

The MHRA says it will publish anonymous data on suspected side effects on its website, enabling both researchers and patients access more detailed information. It adds that every request will be reviewed by an independent committee to make sure it is both ethically and scientifically sound and protects patient confidentiality, with separate measures in place to prevent the potential abuse of the information.

Health Minister, Lord Warner, welcomed the announcement, saying: “The data generated through the scheme can be used to further research and improve drug safety in the UK – patients can see the information used to make decisions about medicines safety and researchers can use this important resource to aid research.”

However, critics are sceptical about the timing of the announcement, which coincides with Government’s health select committee investigation into the pharmaceutical industry’s influence [[21/06/04b]]. It also clearly comes at a time when concern over drug safety is at an all-time high across the globe, exacerbated by Merck & Co’s recent withdrawal of its lead pain-killer, Vioxx (rofecoxib) [[01/10/04a]], and a raft of disappointments and criticisms of other drugs [[20/12/04b]], [[22/11/04a]], [[20/12/04a]].